Autolus Therapeutics has announced that it will assess the feasibility of Cellares’ Cell Shuttle platform to complement its commercial manufacturing operations at the Nucleus facility in Stevenage, UK.
Autolus commercialises AUCATZYL (obecabtagene autoleucel; obe-cel), an autologous CD19 CAR T cell therapy approved in the United States, UK and Europe for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (r/r B-ALL).
Obe-cel is also being studied in ongoing clinical trials to potentially expand its use in pediatric r/r B-ALL and autoimmune diseases, such as lupus and multiple sclerosis.
Cellares’ Cell Shuttle platform integrates all unit operations for CAR T manufacturing into a single-use, closed, pre-sterilised cartridge operated on a fully automated platform capable of processing up to 16 patient batches in parallel.
This architecture enables a single IDMO Smart Factory to deliver up to ten-fold higher throughput than conventional cell therapy manufacturing facilities of similar footprint and headcount, while providing partners with more consistent batch quality, lower cost and greater resilience in commercial supply.
Cellares pairs the Cell Shuttle with Cell QTM, a purpose-built quality control platform for cell therapy drug products that transforms analytical testing from manual, fragmented workflows into automated, high-throughput methods with fully digital, compliant batch records.
The Cellares Cell Shuttle platform was the first to receive the FDA’s Advanced Manufacturing Technology (AMT) designation, which offers partners additional touchpoints and priority review mechanisms when referencing the platform in their INDs, BLAs and post-approval supplements.
“We are evaluating obe-cel in a range of indications beyond acute leukaemia and if successful, expect future demand to exceed the manufacturing capacity at our Nucleus facility."
"Cellares’ Cell Shuttle platform may provide an attractive option for a capital-efficient expansion of our manufacturing footprint in the future,” said Dr Christian Itin, CEO of Autolus.
"If a commercial CAR T shows durable benefit, the next question is whether the industry can produce enough doses at a sustainable cost," said Fabian Gerlinghaus, co-founder and CEO of Cellares.
"Autolus has already built a strong manufacturing foundation."
"Our role is to extend that foundation with a global infrastructure that can reduce cost and process failure rates, while meeting total patient demand."